CN1799613A - Chinese medicine for treating damp heat arthralgia and its preparation method - Google Patents
Chinese medicine for treating damp heat arthralgia and its preparation method Download PDFInfo
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Abstract
The invention provides a traditional Chinese medicinal composition for treating damp-heat rheumatism, which is prepared from twelve kinds of Chinese herbs including atractylodes rhizome, corktree bark, honey-suckle stem and tetrandra root, the dosage types include any pharmacologically acceptable oral medications. The invention also provides the process for preparing the Chinese medicament, especially the process for preparing dispersible tablet, micro balloons and capsules, as well as the preparing process.
Description
Technical field
The present invention relates to field of traditional Chinese, in particular to a kind of Chinese medicine for the treatment of damp and hot numbness and preparation method thereof.
Background technology
Damp and hot numbness resistance is one of common card shape in the traditional Chinese medical science rheumatism, is the common clinical card, and it has a strong impact on people's quality of life.Such disease forms reason has the medicine of sweet savoury of surfeit cream and temperature compensation to cause plain body preponderance of YANG QI, in intrinsic heat is arranged, so the damp that is affected by the cold is easily from transconversion into heat; Or with the passing of time disease do not heal, the with the passing of time heat-transformation of heresy that wind and cold is damp and hot, damp and hot numbness resistance joint passages through which vital energy circulates and send out disease all.Show as arthralgia, heating, or the whole body heating is arranged, and red tongue with yellow fur or greasy, rolling pulse or number are more common in rheumatismal active stage performance such as rheumatoid arthritis, ankylosing spondylitis, gout.Wherein rheumatoid arthritis (RA) be a kind of be feature with the joint synovitis disease, be the chronic autoimmune function disorder disease of main clinical manifestation with the symmetry polyarthritis.Primary disease is sent out in person between twenty and fifty and juvenile well, is a kind of common frdquently encountered disease, women's sickness rate is higher than the male, men and women patient's ratio is 1: 1.5～8, and the rheumatoid arthritis chronic inflammatory disease is not limited only to joint and joint surrounding tissue, can be with organ and tissue system infringements such as the abarticular heart, lung, blood vessels.So this disease is a kind of disease that can make the serious harm health of people that the people disables, pain is continuous and is not healed unbearably during its morbidity, is called as " not dead cancer ".Because etiology unknown is true, doctor trained in Western medicine does not still have specific treatment, western medical treatment adopts the nonsteroidal anti-inflammatory drug treatment more, but all based on pain relieving, progress that only can local disease controlling can not effectively fundamentally be treated such disease, simultaneously drug side effect incidence rate height, cause other complication easily, have a strong impact on patient's health.Clinical observation in recent years, utilization Chinese medicine primary disease is evident in efficacy.And gout is that uric acid concentration continues to raise and what cause serve as the metabolic disease that mainly shows with joint and kidney damage in a kind of purine metabolic disturbance or the body.Hyperuricemia is its important biochemical character.Along with greatly enriching of China's rapid economy development and food, the intake of high protein, high heat food also significantly raises.The generation of metabolic disease relevant with it such as gout and hyperuricemia is also on the rise.The traditional Chinese medical science is the basic principle of treatment with the clearing away heat-damp and promoting diuresis collateral dredging, uses Chinese medicine preparation debating on disease and the dialectical basis that combines, and gives full play to the advantage of Chinese traditional treatment, and Chinese medicine is better than Western medicine on therapeutic effect.At present, the medicine of various these type of diseases of treatment on the market, effect all is not very desirable.
Raising along with people's living standard, the improvement of living environment, the menu routine of high heat etc., modern's physical factors has had bigger variation than ancients, damp and hot numbness resistance disease day by day in rheumatism more sees, the Chinese medicine of the damp and hot numbness of treatment provided by the present invention has clearing heat for detumescence, the effect of removing obstruction in the collateral to relieve pain, not only damp and hot numbness resistance disease there is better curative effect, rheumatoid arthritis, ankylosing spondylitis, gout are also had certain therapeutical effect, are a kind of safe and effective medicine that rheumatism belongs to damp and hot numbness type for the treatment of.
Summary of the invention
The object of the present invention is to provide a kind of Chinese medicine for the treatment of damp and hot numbness, little, the taking convenience of determined curative effect, toxic and side effects of this Chinese medicine.
The present invention also provides this preparation method of Chinese medicine.
Chinese medicine of the present invention is prepared from by acceptable auxiliary on following weight parts proportion raw material and the pharmaceutics:
Rhizoma Atractylodis 50-80 Caulis Lonicerae 100-150 Pheretima 50-80 Fructus Forsythiae 80-115
Cortex Phellodendri 50-80 Semen Coicis 100-150 Radix Saposhnikoviae 50-80 Radix Clematidis 55-95
Radix Stephaniae Tetrandrae 80-115 Radix Cyathulae 80-115 Rhizoma Dioscoreae Hypoglaucae 80-115 Ramulus Mori 100-150.
The weight portion proportion optimization of above-mentioned raw materials:
Rhizoma Atractylodis 60-70 Caulis Lonicerae 125-135 Pheretima 60-70 Fructus Forsythiae 95-105
Cortex Phellodendri 60-70 Semen Coicis 125-135 Radix Saposhnikoviae 60-70 Radix Clematidis 75-85
Radix Stephaniae Tetrandrae 95-105 Radix Cyathulae 95-105 Rhizoma Dioscoreae Hypoglaucae 95-105 Ramulus Mori 125-135.
The weight portion proportion optimization of above-mentioned raw materials:
Rhizoma Atractylodis 50 Caulis Loniceraes 100 Pheretimas 50 Fructus Forsythiaes 80
Cortex Phellodendri 50 Semen Coiciss 100 Radix Saposhnikoviaes 50 Radix Clematidis 55
Radix Stephaniae Tetrandrae 80 Radix Cyathulaes 80 Rhizoma Dioscoreae Hypoglaucae 80 Ramulus Moris 100.
The weight portion proportion optimization of above-mentioned raw materials:
Rhizoma Atractylodis 60 Caulis Loniceraes 135 Pheretimas 70 Fructus Forsythiaes 110
Cortex Phellodendri 70 Semen Coiciss 135 Radix Saposhnikoviaes 60 Radix Clematidis 90
Radix Stephaniae Tetrandrae 105 Radix Cyathulaes 110 Rhizoma Dioscoreae Hypoglaucae 110 Ramulus Moris 125.
The weight portion proportioning of above-mentioned raw materials is also preferred:
Rhizoma Atractylodis 70 Caulis Loniceraes 135 Pheretimas 70 Fructus Forsythiaes 105
Cortex Phellodendri 70 Semen Coiciss 135 Radix Saposhnikoviaes 70 Radix Clematidis 85
Radix Stephaniae Tetrandrae 105 Radix Cyathulaes 105 Rhizoma Dioscoreae Hypoglaucae 105 Ramulus Moris 135.
The weight portion proportioning of above-mentioned raw materials is also preferred:
Rhizoma Atractylodis 80 Caulis Loniceraes 100 Pheretimas 80 Fructus Forsythiaes 80
Cortex Phellodendri 80 Semen Coiciss 100 Radix Saposhnikoviaes 80 Radix Clematidis 95
Radix Stephaniae Tetrandrae 80 Radix Cyathulaes 80 Rhizoma Dioscoreae Hypoglaucae 80 Ramulus Moris 100.
The weight portion proportioning of above-mentioned raw materials is also preferred:
Rhizoma Atractylodis 65.85 Caulis Loniceraes 131.70 Pheretimas 65.85 Fructus Forsythiaes 98.70
Cortex Phellodendri 65.85 Semen Coiciss 131.70 Radix Saposhnikoviaes 65.85 Radix Clematidis 78.90
Radix Stephaniae Tetrandrae 98.70 Radix Cyathulaes 98.70 Rhizoma Dioscoreae Hypoglaucae 98.70 Ramulus Moris 131.70.
Preparation of the present invention can be prepared into acceptable oral Pharmaceutical dosage forms on any pharmaceutics according to the common process of this area.Preferred tablet, granule, capsule, pellet or dispersible tablet.
Adjuvant among the present invention is an acceptable auxiliary on the pharmaceutics, for example starch, dextrin, betacyclodextrin, magnesium stearate, Pulvis Talci, aspartame, stevioside, micropowder silica gel, microcrystalline Cellulose, cross-linked carboxymethyl cellulose, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose sodium, carboxymethyl starch sodium etc.Preferred betacyclodextrin, dextrin, microcrystalline Cellulose.
Capsule of the present invention can be made by the method for being prepared as follows:
More than 12 flavor medical materials, Fructus Forsythiae, Semen Coicis, Radix Stephaniae Tetrandrae are ground into fine powder, all the other Pheretimas etc. nine flavor decocts with water, collecting decoction filters, the relative density that filtrate is concentrated into 50 ℃ of surveys is the clear paste of 1.10-1.30.Above-mentioned fine powder and clear paste are granulated, incapsulate, promptly.
Capsule of the present invention also can be made by the method for being prepared as follows:
More than 12 flavor medical materials, Fructus Forsythiae, Semen Coicis, Radix Stephaniae Tetrandrae are ground into fine powder, all the other Pheretimas etc. nine flavor decocts with water, collecting decoction filters, the relative density that filtrate is concentrated into 50 ℃ of surveys is the clear paste of 1.10-1.30.Above-mentioned fine powder is mixed with clear paste, and drying is pulverized, and incapsulates, promptly.
Capsule of the present invention also can be made by the method for being prepared as follows:
1) Rhizoma Atractylodis, Fructus Forsythiae, Radix Saposhnikoviae three flavors extract volatile oil, and medicinal residues discard, and volatile oil and medicinal liquid are standby;
2) press volatile oil: betacyclodextrin=1: the 4-10 enclose, get volatile oil clathrate compound, standby;
3) nine flavors such as all the other Pheretimas, Cortex Phellodendri decoct with water 2-3 time, and each 1-2 hour, the gained medical filtration, merging filtrate is with 1) the medicinal liquid merging, filtrate is concentrated into fluid extract, and is standby;
4) getting above-mentioned fluid extract adds ethanol and makes the alcohol amount of containing reach 50-80%.Above-mentioned medicinal liquid is stirred evenly, leave standstill.Get supernatant, decompression recycling ethanol, the relative density that is concentrated into 50 ℃ of surveys is the clear paste of 1.20-1.30, and is standby;
5) with above-mentioned clear paste, volatile oil clathrate compound and proper auxiliary materials are granulated, and incapsulate promptly.
Preparation of the present invention can be made micropill by the method for being prepared as follows:
1) Rhizoma Atractylodis, Fructus Forsythiae, Radix Saposhnikoviae three flavors extract volatile oil, and the residue medicinal residues discard, and volatile oil and medicinal liquid are standby.
2) press volatile oil: betacyclodextrin=1: 4-10, enclose gets volatile oil clathrate compound, and is standby.
3) nine flavors such as all the other Pheretimas, Cortex Phellodendri decoct twice, with 1) the medicinal liquid merging, filter, filtrate is condensed into fluid extract, adds ethanol to leave standstill, and gets supernatant, and the relative density that recovery ethanol is concentrated into 50 ℃ of surveys is the clear paste of 1.10-1.30.With the adjuvant is end powder, gets its clear paste, adds volatile oil clathrate compound, the preparation micropill, and coating or coating not, promptly.
Preparation of the present invention also can be made micropill by the method for being prepared as follows:
Fructus Forsythiae, Semen Coicis, Radix Stephaniae Tetrandrae are ground into fine powder, and be standby.Nine flavors such as all the other Pheretimas, Cortex Phellodendri decoct twice, merge medicinal liquid, filter, and centrifugal, the relative density that filtrate is concentrated into 50 ℃ of surveys is the clear paste of 1.10-1.30.With adjuvant and crude drug powder is end powder, gets its clear paste, the preparation micropill; Perhaps, with the micropill coating, promptly.
Preparation of the present invention can be made dispersible tablet by the method for being prepared as follows:
1) Rhizoma Atractylodis, Fructus Forsythiae, Radix Saposhnikoviae three flavors extract volatile oil, and the residue medicinal residues discard, and volatile oil and medicinal liquid are standby.
2) press volatile oil: betacyclodextrin=1: 4-10, enclose gets volatile oil clathrate compound, and is standby.
3) nine flavors such as all the other Pheretimas, Cortex Phellodendri decoct with water 2-3 time, and each 1-2 hour, the gained medical filtration, merging filtrate is with 1) the medicinal liquid merging, filtrate is concentrated into fluid extract, and is standby.
4) getting above-mentioned fluid extract adds ethanol and makes the alcohol amount of containing reach 50-80%.Above-mentioned medicinal liquid is stirred evenly, leave standstill.Get supernatant, decompression recycling ethanol, what concentrate 50 ℃ of surveys is the clear paste of 1.10-1.30 to relative density, standby.
5) with above-mentioned clear paste, volatile oil clathrate compound and proper auxiliary materials are granulated, and drying is made dispersible tablet, and packing promptly.
Preparation of the present invention indication clinically is an expelling wind and removing dampness, clearing heat for detumescence, dredging collateral to stop pain.Be used for numbness disease due to the damp and hot resistance network, disease is seen muscle or redness and swelling of joints burning pain, and sense of heaviness is arranged, and walks with difficulty heating, feeling thirst but no desire to drink, urine yellow skin.Specifically can be used for treating diseases such as rheumatic arthritis, ankylosing spondylitis, gout.
Confirm that through clinical experiment Chinese medicine preparation of the present invention has significant curative effect to the damp and hot numbness of the present invention, and toxic and side effects is little, taking convenience.Concrete experimental data is as follows:
Test a damp and hot numbness sheet pharmacodynamics test
Test two damp and hot arthralgia eliminating granule III phase clinical experiment final reports
Test three damp and hot numbness sheet III phase clinical experiment final reports
Damp and hot numbness sheet pharmacodynamics test
Summary: damp and hot numbness sheet gastric infusion, can obviously suppress Oleum Tiglii induced mice ear swelling; Carrageenin causes rat paw edema, can obviously reduce the abdominal cavity capillary permeability due to the H+; Reduce acetic acid induced mice writhing response number of times; Delayed hypersensitive reaction due to the DNCB there is the obvious suppression effect; Draft beer yeast pyrogenicity rat there is tangible antipyretic effect.
Purpose: damp and hot numbness sheet in clinical practice for a long time, the damp and hot arthromyodynia of treatment muscle or redness and swelling of joints burning pain has obtained satisfied curative effect, pharmacodynamic experiment is mainly studied its expelling wind and removing dampness, clearing heat for detumescence, effects such as dredging collateral to stop pain.
Experiment material:
Tested medicine: damp and hot numbness sheet, the 3rd pharmaceutical factory provides by Benxi, Liaoning Province, and every plain sheet weighs 0.25 gram, is equivalent to crude drug 0.75 gram, lot number: 990701
Positive controls: FENGSHIBIKANG JIAONANG, produce by Chinese-foreign joint Jilin Hua Jia pharmaceutcal corporation, Ltd, every heavy 0.3 gram, commercially available, lot number: 9901043
Animal: rat Wista numbness kind, white mice HM kind, Liaoning Province animal housing of medicine technical study institute provides.The quality certification number: No. 003, the real moving word of the Liao Dynasty.
Experimental technique:
1. Oleum Tiglii is brought out the influence of mice ear
40 of male white mouses, body weight 25～30g is divided into 4 groups immediately, 10 every group, irritates stomach respectively and gives the low dose of 2.48g/kg of damp and hot numbness sheet and heavy dose of 4.95g/kg (calculating by containing the crude drug amount); Positive drug control group gives FENGSHIBIKANG JIAONANG 0.33g/kg, and matched group waits the normal saline of capacity.Each treated animal gastric infusion every day once, successive administration 4 days, 1h after the last administration, be applied to two sides, animal auris dextra front and back respectively with 2% Oleum Tiglii mixing proinflammatory agent, every Mus 0.1ml behind the 4h puts to death the disconnected neck of animal, and every Mus cuts off left and right two ears, with 9mm diameter card punch, lay round auricle at same position respectively and weigh.As swelling degree index, carry out statistical procedures with the left and right two ear method of double differences values of every Mus, relatively each group difference the results are shown in Table 1.
The damp and hot numbness sheet of table 1 brings out the influence of mice ear to Oleum Tiglii
| Group | Dosage (g/kg) | Animal (only) | The swelling degree (X ± SD, mg) |
| The damp and hot numbness sheet of the contrast damp and hot numbness sheet of FENGSHIBIKANG | - 0.33 2.48 4.95 | 10 10 10 10 | 19.65±2.69 16.24±2.70* 15.47±2.80** 12.05±2.90** |
* compare with matched group P＜0.05 * * P＜0.01
Table 1 is the result show, damp and hot numbness sheet can obviously suppress Oleum Tiglii induced mice ear swelling, and tangible antiinflammatory action is arranged.
2. dish glue in diagonal angle causes the influence of big tree foot swelling.
40 of male rats, body weight 120～150g is divided into 4 groups at random, and 10 every group, to irritate stomach respectively and give the low dose of 1.22g/kg of damp and hot numbness sheet and heavy dose of 2.43g/kg (by the crude drug amount), positive drug control group gives FENGSHIBIKANG JIAONANG 0.16g/kg.Matched group waits the capacity normal saline, each treated animal is irritated stomach equal every day and is given once, in 1 week of successive administration, after the last administration 30 minutes, left back sufficient sole of the foot intradermal injection 1% carrageenin 0.05ml caused inflammation in each rat, before measuring administration, after the administration 1,2,3,4,6h ankle joint Zhou Jing, the difference that causes scorching forward and backward ankle joint Zhou Jing with each rat is the swelling degree, calculates and respectively organizes swelling degree average and standard deviation, relatively each group difference the results are shown in Table 2.
The influence of rat paw edema due to the damp and hot numbness sheet of the table 2 diagonal angle dish glue
| Group | Dosage (g/kg) | Animal (only) | The rat paw edema degree (X ± SD, cm) | ||||
| 1h | 2h | 3h | 4h | 6h | |||
| The damp and hot numbness sheet of the contrast damp and hot numbness sheet of FENGSHIBIKANG | - 0.16 1.22 2.43 | 10 10 10 10 | 0.77±0.13 0.57±0.09** 0.55±0.08** 0.64±0.07* | 0.78±0.15 0.65±0.12* 0.63±0.09* 0.67±0.06* | 0.78±0.11 0.67±0.11* 0.65±0.10* 0.70±0.06* | 0.84±0.12 0.72±0.09** 0.70±0.10* 0.73±0.10* | 0.70±0.11 0.61±0.10** 0.57±0.11* 0.645±0.11* |
Compare with matched group * P＜0.05 * * P＜0.01
Table 2 is the result show, damp and hot numbness sheet can obviously suppress rat paw edema due to the carrageenin, and the obvious anti-inflammatory and anti effect is arranged.
3. to the influence of abdominal cavity hair cell vascular permeability
40 of male white mouses, body weight 19～21g is divided into 4 groups at random, every group 10, every day gastric infusion once, successive administration 9 days, 1h after the last administration, the blue 0.1ml/10g of tail vein injection 1% ivens, the abdominal cavity only injects 0.7% glacial acetic acid 0.2ml/ immediately, sacrificed by decapitation after 20 minutes, a lumbar injection 5ml/ normal saline is drawn peritoneal fluid, gets supernatant and surveys trap in the 599nm place in centrifugal 15 minutes, relatively each group difference the results are shown in Table 3.
The damp and hot numbness sheet of table 3 influences the abdominal cavity capillary permeability
| Group | Dosage (g/kg) | Number of animals (only) | Optical density (X ± SD, mg) |
| The damp and hot numbness sheet of the damp and hot numbness sheet of matched group FENGSHIBIKANG | - 0.33 2.48 4.95 | 10 10 10 10 | 0.457±0.14 0.328±0.10* 0.334±0.08* 0.247±0.12** |
* compare with matched group P＜0.05 * * P＜0.01
Table 3 result shows: damp and hot numbness sheet strengthens the abdominal cavity blood capillary general character due to the glacial acetic acid obvious inhibitory action.
4. Dichlorodiphenyl Acetate causes the influence of pain
40 of male and female white mice, body weight 18～22g is divided into 4 groups at random, every group 10, every day gastric infusion once, successive administration 7 days, 40 minutes each Mus lumbar injection 0.7% acetum 0.2ml/ of last administration only, immediately in the opening entry 20 minutes each mice turn round the body number of times, the results are shown in Table 4.
The damp and hot numbness sheet of table 4 is to the influence of mice acetic acid twisting reaction
| Group | Dosage (g/kg) | Number of animals (only) | The writhing response number of times (X ± SD) |
| The damp and hot numbness sheet of the damp and hot numbness sheet of matched group FENGSHIBIKANG | - 0.33 2.48 4.95 | 10 10 10 10 | 26.0±7.29 16.8±9.0* 17.4±7.3* 6.6±4.2** |
* compare with matched group P＜0.05 * * P＜0.01
Table 4 is the result show, what damp and hot numbness sheet can obviously reduce acetic acid induced mice abdominal pain turns round the body number of times, and obvious analgesic activity is arranged.
5. to the influence of delayed hypersensitivity due to the DNCB
40 of white mice, body weight 18～21g is divided into 4 groups at random, give mouse back subcutaneous injection 0.02ml/ only with the 6%DNCB acetone solution, sensitization same day, gastric infusion respectively, once a day, continuous 8 days, be coated with auris dextra with the 1%DNCB acetone soln on the 7th day in sensitization, put to death mice behind the 24h, the difference heavy with left and right sides ear is the delayed hypersensitivity index, relatively each group difference the results are shown in Table 5.
The damp and hot numbness sheet of table 5 is to the influence of delayed hypersensitivity due to the DNCB
| Group | Dosage (g/kg) | Number of animals (only) | The ear method of double differences (X ± SD, mg) |
| The damp and hot numbness sheet of the damp and hot numbness sheet of matched group FENGSHIBIKANG | - 0.33 2.46 4.95 | 10 10 10 10 | 2.72±0.67 1.87±0.82* 1.97±0.71* 1.36±0.68** |
* compare with matched group P＜0.05 * * P＜0.01
Table 5 result shows that damp and hot numbness sheet can obviously reduce the ear swelling degree of delayed hypersensitivity due to the DNCB, has the obvious suppression effect to the delayed hypersensitivity due to the DNCB.
6. analgesic experiment
Female rat body weight 140～190g, every day gastric infusion once, successive administration 7 days, the same day was surveyed the rat rectal temperature with digital clinical thermometer simultaneously with rat difference back subcutaneous injection 20% beer yeast suspension 20ml/kg in the last administration, was divided into 4 groups more than 0.8 ℃ at random to all fervescence behind the sterilised yeast suspension 5h, the difference gastric infusion once behind the injection yeast 6h, 0.5h, 1h, 2h survey rat temperature respectively after the administration, carry out statistical procedures, the results are shown in Table 6.
The damp and hot numbness sheet of table 6 is to the influence of rat temperature due to the beer yeast
| Group | Dosage (g/kg) | Number of animals (only) | Body temperature after the administration (X ± SD, ℃) | ||
| 0.5h | 1h | 2h | |||
| The damp and hot numbness sheet of the contrast damp and hot numbness sheet of FENGSHIBIKANG | - 0.16 1.22 2.43 | 10 10 10 10 | 40.06±0.5 39.7±0.4 39.5±0.3* 39.3±0.5** | 40.1±0.4 40.0±0.3 39.4±0.4** 39.2±0.5** | 39.8±0.4 39.7±0.4 39.6±0.4 39.2±0.4* |
* compare with matched group P＜0.05 * * P＜0.01
Table 6 result shows that damp and hot numbness sheet can reduce obviously that rat temperature raises due to the beer yeast, has tangible refrigeration function.
Conclusion:
Above-mentioned pharmacodynamics test result of study shows that damp and hot numbness sheet has expelling wind and removing dampness, clearing heat for detumescence, dredging collateral to stop pain effect.
Damp and hot arthralgia eliminating granule III phase clinical experiment final report
Damp and hot arthralgia eliminating granule is one of sick serial medicine of national three kind new medicine numbness, for Chinese Chinese medicine and pharmacy is understood rheumatism association cipher prescription, and the damp and hot numbness resistance syndrome in the treatment traditional Chinese medical science rheumatism.This medicine is chosen as national essential drugs, and Chinese medicine protection kind and " medical insurance " medication by national requirements, need that this medicine is carried out clinical efficacy and revalue, and carry out safety investigation spy and carry out III phase clinical experiment.From April in August, 2000 to calendar year 2001, can the tissue whole nation 12 tame hospitals of rheumatism association carry out open clinical observation by Chinese Chinese medicine and pharmacy, observe patient's 400 examples altogether, test group 298 examples wherein, matched group 102 examples now are reported as follows the result.
General material
One, case source: this group is totally 400 examples, inpatient's 120 examples wherein, outpatient's 280 examples.
Two, sex: two groups of patient's sex ratios see Table 1
Table 1 liang group patient sex ratio
| Group | The example number | The male | The women | ||
| N | (％) | N | (％) | ||
| The test group matched group | 298 102 | 160 35 | (53.7) (47.1) | 148 54 | (49.7) (52.9) |
Test group and matched group compare: X
2=0.732 P＞0.05
Two groups of patients there was no significant difference on sex distributes is described, has comparability.
Three, two groups of patient ages distribute relatively, see Table 2
Table 2 liang group patient age distribution comparison (year)
| Group | The example number | ≤30 N(％) | 31～40 N(％) | 41～50 N(％) | 51～65 N(％) | Mean age X ± S |
| The test group matched group | 298 102 | 53(17.8) 16(15.7) | 65(21.8) 28(27.5) | 96(32.2) 28(27.5) | 84(28.2) 30(29.4) | 41.16±10.9 39.68±9.98 |
Test group and matched group compare: X
2=1.829 P＞0.05
Two groups of patients there was no significant difference in age distribution is described, has comparability.
Four, two groups of patient's courses of disease relatively see Table 3
The table 3 liang group patient course of disease relatively
| Group | The example number | ≤ 6 months N (%) | Half a year～N (%) | 2 years～N (%) | 5 years～N (%) | 10 years～N (%) | Average course of disease X ± S |
| The experimental group matched group | 298 102 | 61(20.5) 15(14.7) | 62(20.8) 24(23.5) | 78(26.2) 32(31.4) | 47(15.8) 19(18.6) | 50(16.8) 12(11.8) | 3.9±3.70 4.84±4.4 |
Test group and matched group compare: X
2=3.945 P＞0.05
Illustrate that two groups of patients relatively go up there was no significant difference in the course of disease, have comparability.
Five, the sick kind distributes relatively, sees Table 4
The sick kind of table 4 distributes relatively
| Group | The example number | RA N(％) | AS N(％) | gout N(％) | OA N(％) |
| The test group matched group | 298 102 | 188(63.1) 69(67.6) | 43(14.4) 14(11.8) | 54(18.1) 21(20.6) | 13(4.4) 0 |
Test group and matched group compare: X
2=5.334 P＞0.05
Two groups of patients there was no significant difference on the disease kind distributes is described, has comparability.
Six, syndrome degree: two groups of patient's syndrome degree relatively see Table 5
Table 5 liang group patient syndrome degree relatively
| Group | The example number | Slight N (%) | Moderate N (%) | Severe N (%) |
| The test group matched group | 298 102 | 49(16.4) 8(7.9) | 161(54.1) 61(59.8) | 88(29.5) 33(32.3) |
Test group and matched group compare: X
2=4.60 P＞0.05
Two groups of patients there was no significant difference on the syndrome degree is described, has comparability.
Test method
One. diagnostic criteria
(1) syndrome of dampness-heat blocking collaterals
The redness and swelling of joints burning pain has sense of heaviness, the heating that touch the part, feeling thirst but no desire to drink, red tongue with yellowish and greasy fur, slippery and rapid pulse
(2) Western medicine diagnose standard
According to the therapeutic efficiency of damp and hot numbness (tablet, granule), select sick kind of following doctor trained in Western medicine to carry out clinical observation.
1. rheumatoid arthritis (RA) diagnostic criteria (Americanism damp disease association revision diagnostic criteria in 1987)
(1) morning deadlock at least 1 hour, continued at least 6 weeks.
(2) 3 or the arthroncus more than 3 continued at least 6 weeks.
(3) carpal joint, metacarpophalangeal joints or 6 weeks of nearly articulations digitorum manus swelling or more than.
(4) symmetry arthroncus.
(5) the X line of hands changes.
(6) rheumatoid nodules.
(7) the rheumatoid factor positive.
In above-mentioned 7, have 4 or above person and can be diagnosed as RA.
2. gout (Holmes 1985)
(1) in the leukocyte of synovial bursa hydrops, urate crystal is arranged;
(2) in suction of tophus pin or the biopsy urate crystal is arranged;
(3) do not find special urate crystal, but hyperuricemia is arranged, typical acute arthritis is shown effect and the asymptomatic intermission, and treatment has specially good effect person to colchicine.
3. ankylosing spondylitis diagnostic criteria (the New York standard of revision in 1984)
(1) clinical criteria
1. low back pain continues at least 3 months, can alleviate after the activity, has a rest not have and improves
2. lumbar vertebra is at the limitation of activity of vertical and horizontal plane
3. the thorax mobility be lower than corresponding age, property others
(2) radiology standard
3～4 grades of bilateral sacroiliitis 〉=2 grade or one-sided sacroiliitises
Make a definite diagnosis: meet radiology standard and 1 above clinical criteria.
Two. test case standard
(1) case is included standard in
1. meet above-mentioned tcm syndrome standard and certain Western medicine diagnose person, all can include the object of observation in.
2. the age is between 18～65 years old.
(2) case is got rid of and the rejecting standard
1. do not meet and include standard person in.
2. gestation or women breast-feeding their children, serious primary diseases such as allergic constitution or this medicine allergy sufferers merged is had the inclination, cerebrovascular, liver, kidney, hemopoietic system, psychotic.
3. not medication in accordance with regulations can't be judged the infull person of curative effect or data.
Three. observational technique
(1) medicine
1. test drug: damp and hot arthralgia eliminating granule, specification: granule is the 10g/ bag; Provide by the production of Benxi, Liaoning Province the 3rd pharmaceutical factory.
2. contrast medicine: ZHENGQINGFENGTONGNING PIAN, specification are the 20mg/ sheet, produce (authentication code: ZZ-5365 defends in Hunan the accurate word 1992 of medicine No. 023069) by Zhengqing Pharmaceutical Group Corp., Ltd., Hunan Prov., and Benxi the 3rd pharmaceutical factory provides.
(2) test method
1. the object of observation is for being in hospital and the out-patient.
2. grouping: adopt contrast method at random, case is pressed groups of grains: the tablet group: matched group distributes, and ratio is 3: 3: 1.
3. medication: groups of grains, each 1 bag, 3 times on the one; The tablet group, each 6,3 times on the one; Matched group, 2 of first clothes, 3 times on the one, having no adverse reaction after the week adds to each 3, three times on the one.
4. course of treatment: rheumatoid arthritis and ankylosing spondylitis, be 2 months the course of treatment; Gout course of treatment is 1 month.
Four. observation index
(1) safety observation
1. general health check-up project
2. blood, urine, just routine examination
3. electrocardiogram, liver, kidney function test
(2) health giving quality observation
1. symptom grade scale:
1. arthralgia:
0 minute: do not have
1 minute: mild pain, can stand, do not influence sleep.
2 minutes: moderate pain, inertia be pain also.
3 minutes: pain was difficult to stand, and influences function.
2. arthroncus:
0 minute: do not have
1 minute: mild swelling, near bone mark was clear.
2 minutes: swelling was equal with near bone mark.
3 minutes: obviously swelling, bone mark was unclear.
3. articular pain:
0 minute: do not have.
1 minute: weight at the edge, joint or when touching ligament, patient claimed that pain is arranged.
2 minutes: weight patient claimed that pain is arranged, and frowns discomfort, and activity is slightly limited.
3 minutes: the severe tenderness, pressing slightly promptly has pain and shrinks back, and passive activity is seriously limited.
4. morning deadlock:
0 minute: do not have.
1 minute: morning stiff time＜30 minute.
2 minutes: morning stiff time 〉=30 minute,＜60 minutes.
3 minutes: morning stiff time 〉=60 minute.
5. function of joint:
0 minute: function was normal.
1 minute: slightly limited, can be engaged in normal activity.
2 minutes: obviously limited, life can be taken care of oneself, but can not be engaged in general activity.
3 minutes: the movable function forfeiture, can't take care of oneself.
6. the joint heating of touching:
0 minute: do not have
1 minute: have
7. limbs are heavy:
0 minute: do not have
1 minute: have
The mild symptoms major punishment is fixed:
Slightly: integration＜5 minute
Moderate: integration 6～10 minutes
Severe: integration＞10 minute
(2) both hands grip: all write down the numerical value (mmHg) that is reached before and after the treatment.
(3) picture of the tongue pulse condition observation.
(4) laboratory indexes observation: ESR, CRP, RF, blood uric acid.
(5) untoward reaction observation:, itemized record with the relevant untoward reaction of curative possibility.
The symptom efficacy determination:
Control: reduce to 0 fen person through the treatment symptom integral.
Produce effects: reduce by 2 fens persons through the treatment symptom integral.
Effectively: reduce by 1 fen person through the treatment symptom integral.
Five. traditional Chinese medical science disease curative effect determinate standard (according to new Chinese medicine clinical guidance principle standard)
Clinic control: treat the back symptom and disappear substantially, symptom was promptly divided 0～1 fen.
Produce effects: treat the back symptom and be clearly better, symptom is promptly divided decline 〉=2/3
Effectively: treat the back doing well,improving, symptom is promptly divided decline 〉=1/3.
Invalid: as not reach effective standard.
Six. the efficacy assessment standard of treatment rheumatism sexually transmitted disease (STD) in the curative effect of disease standard (with reference to new drug (Western medicine) clinical guidance principle).
Clinical remission: symptom, sign disappear, and the laboratory leading indicator is recovered or be approaching normal.
Produce effects: symptom, sign disappear substantially, and the laboratory leading indicator is obviously improved, decline degree 〉=50%.
Effectively: symptom, sign alleviate, and the laboratory leading indicator also has improvement.
Invalid: symptom, sign and laboratory leading indicator do not have improvement.
Annotate: laboratory indexes computational methods erythrocyte sedimentation rate, c reactive protein, numeral-normal value before the numeral-treatment back numeral/treatment before the treatment; 〉=two dilution factors of rheumatoid factor decline
Result of the test
One, total effects analysis: two groups of clinical total effectses of patient relatively see Table 6
Table 6 liang group patient clinical efficacy relatively
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | The above rate of produce effects | Total effective rate | ||||||
| N | (％) | N | (％) | N | (％) | N | (％) | N | (％) | N | (％) | ||
| The test group matched group | 298 102 | 66 14 | (22.1) (13.7) | 106 36 | (35.6) (35.3) | 85 32 | (28.5) (33.3) | 41 20 | (13.8) (19.6) | 171 50 | (57.7) (49) | 257 82 | (86.2) (80.4) |
Annotate: * total effective rate=clinic control rate+obvious effective rate+effective percentage
Test group and matched group compare: Ridit analyzes u=1.975 P＜0.05
Two, symptom curative effect
1, two groups of patient's arthralgia treatment front and back curative effects relatively see Table 7.
Curative effect relatively before and after the table 7 liang group patient arthralgia treatment
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | ||||
| N | (％) | N | (％) | N | (％) | N | (％) | ||
| The test group matched group | 298 102 | 113 24 | (37.9) (23.5) | 97 31 | (32.6) (30.4) | 54 37 | (18.1) (36.3) | 34 10 | (11.4) (9.8) |
Test group and matched group compare: U=2.725 P＜0.01
Illustrate: test group is being better than matched group aspect the arthralgia curative effect.
2, two groups of patient's arthroncus treatment front and back curative effects relatively see Table 8.
Curative effect relatively before and after the table 8 liang group patient arthroncus treatment
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | ||||
| N | (％) | N | (％) | N | (％) | N | (％) | ||
| The test group matched group | 273 94 | 107 27 | (39.2) (28.7) | 75 22 | (27.5) (23.4) | 60 25 | (22) (26.6) | 31 20 | (11.3) (21.3) |
Test group and matched group compare: U=2.531 P＜0.05
Illustrate: test group is being better than matched group aspect the arthroncus curative effect.
3, two groups of patient's articular pain treatment front and back curative effects relatively see Table 9.
Curative effect relatively before and after the table 9 liang group patient articular pain treatment
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | ||||
| N | (％) | N | (％) | N | (％) | N | (％) | ||
| The test group matched group | 270 85 | 80 13 | (29.7) (15.3) | 84 29 | (31) (34.1) | 43 19 | (16) (22.3) | 63 24 | (23.3) (28.2) |
Test group and matched group compare: U=2.222 P＜0.05
Illustrate: test group is being better than matched group aspect the articular pain curative effect.
4, two groups of patient's joint function disturbance treatment front and back curative effects relatively see Table 10.
Curative effect relatively before and after the table 10 liang group patient joint function disturbance treatment
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | ||||
| N | (％) | N | (％) | N | (％) | N | (％) | ||
| The test group matched group | 264 93 | 92 6 | (34.8) (6.5) | 67 24 | (25.4) (25.8) | 32 25 | (12.1) (26.9) | 73 38 | (27.6) (40.8) |
Test group and matched group compare, U=4.717 P＜0.01
Test group is being better than matched group aspect the joint function disturbance curative effect.
5, two groups of fever therapy front and back curative effect comparisons that touch in the patient joint see Table 11.
Curative effect relatively before and after the table 11 liang fever therapy that touch in group patient joint
| Group | The example number | N before the treatment | Treatment back N | Disappearance rate | |
| N | (％) | ||||
| The test group matched group | 298 98 | 216 82 | 43 24 | 173 58 | (80) (70.7) |
Test group and matched group compare: U=0.907 P＞0.05
Before and after the fever therapy that test group is touched in the joint aspect the curative effect with matched group there was no significant difference relatively.
Three, the curative effect of the two groups of different sick kind treatment of patient front and back relatively.
1. curative effect relatively sees Table 12 before and after the two category rheumatic arthritis patient treatments.
Curative effect relatively before and after the table 12 liang category rheumatic arthritis patient treatment
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | Total effective rate (%) | ||||
| N | (％) | N | (％) | N | (％) | N | (％) | |||
| The test group matched group | 188 69 | 37 10 | (19.7) (14.5) | 58 17 | (30.9) (24.6) | 70 32 | (37.2) (46.4) | 23 10 | (12.2) (14.5) | 87.8 85.5 |
Test group and matched group compare: Ridit analyzes: u=1.415 P＞0.05
2. two groups of patients with ankylosing spondylitis treatment front and back curative effects relatively see Table 13
Curative effect relatively before and after the table 13 liang group patients with ankylosing spondylitis treatment
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | Total effective rate (%) | ||||
| N | (％) | N | (％) | N | (％) | N | (％) | |||
| The test group matched group | 43 14 | 3 0 | (7) | 8 4 | (18.6) (28.6) | 24 6 | (55.8) (42.9) | 8 2 | (18.6) (28.5) | 81.4 71.5 |
Test group and matched group compare, and Ridit analyzes: U=0.392 P＞0.05
3. two groups of patient with gout treatment front and back curative effects relatively see Table 14
Curative effect relatively before and after the table 14 liang group patient with gout treatment
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | Total effective rate (%) | ||||
| N | (％) | N | (％) | N | (％) | N | (％) | |||
| The test group matched group | 54 21 | 8 1 | (14.8) (4.8) | 14 3 | (25.9) (14.3) | 23 9 | (42.5) (42.9) | 9 8 | (16.6) (38) | 83.4 62 |
Test group and matched group compare, and Ridit analyzes: U=2.132 P＜0.05
Four, the two groups of main laboratory indexes treatment of patient front and back curative effects relatively.
1. curative effect relatively sees Table 15 before and after the erythrocyte sedimentation rate treatment
Curative effect compares X ± S before and after the treatment of table 15 erythrocyte sedimentation rate
| The sick kind | Group | The example number | Before the treatment | After the treatment | P |
| RA AS | Test group matched group test group matched group | 188 102 43 14 | 44.33±21.14 41.88±21.52 30.8±16.3 43.4±28.1 | 26.9±16.09 25.2±13.9 21.8±8.98 28.8±16.04 | ＜0.05 ＜0.05 ＜0.05 ＞0.05 |
Illustrate before and after the test group self significant difference is relatively arranged.Compare RA before and after the matched group self significant difference is arranged.
2.C curative effect relatively sees Table 16 before and after the reactive protein treatment.
Curative effect relatively before and after the treatment of table 16C reactive protein
| The sick kind | Group | The example number | Before the treatment | After the treatment | Negative conversion rate |
| Negative | Positive | Negative | Positive | (％) | |||
| RA AS | Test group matched group test group matched group | 140 59 43 14 | 82 43 25 6 | 58 16 18 8 | 130 52 37 9 | 10 7 6 5 | 82.7 56.2 66 37.5 |
Illustrate before and after the test group self significant difference is relatively arranged; Relatively there is not very significant difference before and after the matched group self; Test group is relatively having significant difference with matched group aspect the reduction c reactive protein curative effect.
3. curative effect relatively sees Table 17 before and after the treatment of rheumatoid arthritis patients rheumatoid factor.
Curative effect relatively before and after the treatment of table 17 rheumatoid factor
| Group | The example number | Before the treatment | After the treatment | Negative conversion rate (%) | ||
| Negative | Positive | Negative | Positive | |||
| The test group matched group | 162 60 | 33 18 | 129 42 | 77 33 | 85 27 | 34.1 35.7 |
Illustrate: compare there was no significant difference before and after the test group self; Compare there was no significant difference before and after the matched group self; Test group is comparing there was no significant difference with matched group aspect the reduction rheumatoid factor curative effect.
4. curative effect relatively sees Table 18 before and after the treatment of patient with gout blood uric acid.
Curative effect compares X ± S before and after the treatment of table 18 patient with gout blood uric acid
| Group | The example number | Before the treatment | After the treatment | P |
| The test group matched group | 54 21 | 615.5±136.6 611.6±109.1 | 362.6±116.9 420.4±115.6 | ＜0.01 ＜0.05 |
Illustrate before and after the test group self significant difference is relatively arranged; Significant difference is relatively arranged before and after the matched group self; Test group is comparing there was no significant difference with matched group aspect the reduction blood uric acid curative effect.
Safety detects
In clinical trial, whole experimenters have been carried out the safety detection, the results are shown in Table 20.
Table 20 experimental group patient safety detects
| Project | The example number | Before the treatment | After the treatment | ||
| Normally | Unusually | Normally | Unusually | ||
| Routine blood test routine urinalysis GPT BUN Cr electrocardiogram | 298 298 241 241 240 241 | 285 292 241 241 240 240 | 13 6 0 0 1 1 | 297 298 241 241 240 240 | 1 0 0 0 1 1 |
Illustrate: the unusual patient's kind of 13 routine routine blood tests, 10 examples raise for leukocyte, and most companion's trips are infected, and behind symptomatic treatment, all recover normal; 3 examples reduce for hematochrome, and 2 examples recover normal after treating.During 6 routine routine urinalysis are unusual, be urinary system infection, after treating, recover normal.1 routine serum creatinine reduces no clinical meaning.
Untoward reaction
No obvious adverse reaction.
The resistance of damp and hot numbness is one of common pattern of syndrome in the traditional Chinese medical science rheumatism, and forming reason has the medicine of sweet savoury of surfeit cream and temperature compensation to cause plain body preponderance of YANG QI, in intrinsic heat is arranged, so the damp that is affected by the cold is easily from transconversion into heat; Or with the passing of time disease do not heal, the with the passing of time heat-transformation of heresy that wind and cold is damp and hot, damp and hot numbness resistance joint passages through which vital energy circulates and send out disease all.Ask numbness opinion institute cloud as element: " how cloudy yang-energy gas is few, and pathogenic QI in the body wins, and sun meets with cloudy, so be numbness heat ".Outstanding behaviours is an arthralgia, the heating of laying one's hand on, or the whole body heating is arranged, and red tongue with yellow fur or greasy, rolling pulse or number are more common in rheumatismal active stage performance such as rheumatoid arthritis, ankylosing spondylitis, gout, the basic principle of the wet treatment of clearing away heat-damp and promoting diuresis collateral dredging.According to the Therapeutic Principle of tcm treatment according to syndrome differentiation, on differential diagnosis of diseases and the dialectical basis that combines, use Chinese medicine preparation, can give full play to the advantage of Chinese traditional treatment.Damp and hot numbness sheet is made up of ten several kinds of Chinese medicinal materials such as Rhizoma Atractylodis, Cortex Phellodendri, raw pearl barley, Caulis Lonicerae, Radixs Stephaniae Tetrandrae, cures mainly the damp and hot numbness resistance card in the traditional Chinese medical science rheumatism.This clinical research is according to the principle of traditional Chinese medical science treating different diseases with the same therapeutic principle, adopt the damp and hot numbness sheet of test group respectively, the damp and hot numbness resistance of the traditional Chinese medical science card of matched group ZHENGQINGFENGTONGNING slow releasing tablet treatment rheumatoid arthritis, ankylosing spondylitis, gout, the clinical research result is as follows: 1, two groups of total effectses are compared: test group 298 examples, above 171 examples of produce effects, obvious effective rate is 57.7%; Total effective rate is 86.2%.Matched group 102 examples, obvious effective rate are 49%; Total effective rate is 82%; Two groups of medicine total effectses are compared (P＜0.05) significant difference.2, each symptom curative effect relatively: test group is being compared significant difference with matched group aspect treatment arthralgia, arthroncus, articular pain, the joint function disturbance.3. curative effect of disease relatively: treatment RA total effective rate is 87.8%, compares there was no significant difference with the contrast resistance; Treatment AS total effective rate is 81.4%, and treatment Gout total effective rate is 83.4%, with matched group significant difference is arranged relatively.4. to the influence of main laboratory indexes: test group treatment back ESR, CRP, RF, blood uric acid all have decline, and significant difference is relatively arranged before and after the treatment.5. security inspection: damp and hot arthralgia eliminating granule does not have obvious adverse reaction, and the heart, liver, kidney, hemogram etc. are all had no adverse effects.
Raising along with people's living standard, the improvement of living environment, the menu routine of high heat etc., modern's physical factors has had great changes than ancients, damp and hot numbness resistance disease day by day in rheumatism more sees, this result of study shows, damp and hot numbness sheet has clearing heat for detumescence really, the effect of removing obstruction in the collateral to relieve pain, not only damp and hot numbness resistance disease there is better curative effect, rheumatoid arthritis, ankylosing spondylitis, gout are also had certain therapeutical effect, are a kind of safe and effective medicine that rheumatism belongs to damp and hot numbness type for the treatment of.
Test unit:
Guang-amen Hospital, China Traditional Chinese Medicine Instl
Shanghai brilliance hospital
Shanghai City institute of traditional Chinese medicine
Henan rheumatism hospital
Luoyang bonesetting hospital
The Beijing Jishuitan Hospital
Hospital Attached to Liaoning Inst. of Traditional Chinese Medicine
Gansu Provincial Hospital of Traditional Chinese Medicine
Tangshan City institute of traditional Chinese medicine
The Provincial Medicine Research Institute, Gansu
466 hospitals of Beijing air force
Benxi Hospital of Traditional Chinese Medicine
Damp and hot numbness sheet III phase clinical experiment final report
Damp and hot numbness sheet is one of sick serial medicine of national three kind new medicine numbness, for Chinese Chinese medicine and pharmacy is understood rheumatism association cipher prescription, and the damp and hot numbness resistance syndrome in the treatment traditional Chinese medical science rheumatism.This medicine is chosen as national essential drugs, and Chinese medicine protection kind and " medical insurance " medication by national requirements, need that this medicine is carried out clinical efficacy and revalue, and carry out safety and investigate, and the spy carries out III phase clinical experiment.From April in August, 2000 to calendar year 2001, can the tissue whole nation 12 tame hospitals of rheumatism association carry out open clinical observation by Chinese Chinese medicine and pharmacy, observe patient's 402 examples altogether, test group 300 examples wherein, matched group 102 examples now are reported as follows the result.
General material
One, case source: this group is totally 400 examples, inpatient's 141 examples wherein, outpatient's 261 examples.
Two, sex: two groups of patient's sex ratios see Table 1
Table 1 liang group patient sex ratio
| Group | The example number | The male | The women | ||
| N | (％) | N | (％) | ||
| The test group matched group | 300 102 | 131 35 | (43.6) (47.1) | 169 54 | (56.3) (52.9) |
Test group and matched group compare: X
2=0.354 P＞0.05
Two groups of patients there was no significant difference on sex distributes is described, has comparability.
Three, two groups of patient ages distribute relatively, see Table 2
Table 2 liang group patient age distribution comparison (year)
| Group | The example number | ≤30 N(％) | 31～40 N(％) | 41～50 N(％) | 51～65 N(％) | Mean age X ± S |
| The test group matched group | 300 102 | 68(22.6) 16(15.7) | 80(26.6) 28(27.5) | 80(26.6) 28(27.5) | 72(24.2) 30(29.4) | 41.92±11.2 39.68±9.98 |
Test group and matched group compare: X
2=2.688 P＞0.05
Two groups of patients there was no significant difference in age distribution is described, has comparability.
Four, two groups of patient's courses of disease relatively see Table 3
The table 3 liang group patient course of disease relatively
| Group | The example number | ≤ 6 months N (%) | Half a year～N (%) | 2 years～N (%) | 5 years～N (%) | 10 years～N (%) | Average course of disease X ± S |
| The experimental group matched group | 300 102 | 54(18.0) 15(14.7) | 78(26.0) 24(23.5) | 80(26.7) 32(31.4) | 62(20.7) 19(18.6) | 26(8.6) 12(11.8) | 4.2±3.22 4.84±4.4 |
Test group and matched group compare: X
2=2.199 P＞0.05
Illustrate that two groups of patients relatively go up there was no significant difference in the course of disease, have comparability.
Five, the sick kind distributes relatively, sees Table 4
The sick kind of table 4 distributes relatively
| Group | The example number | RA N(％) | AS N(％) | gout N(％) | OA N(％) |
| The test group matched group | 300 102 | 174(58) 69(67.6) | 60(20) 14(11.8) | 66(22) 21(20.6) | 0 0 |
Test group and matched group compare: X
2=1.72 P＞0.05
Two groups of patients there was no significant difference on the disease kind distributes is described, has comparability.
Six, syndrome degree: two groups of patient's syndrome degree relatively see Table 5
Table 5 liang group patient syndrome degree relatively
| Group | The example number | Slight N (%) | Moderate N (%) | Severe N (%) |
| The test group matched group | 300 102 | 47(15.7) 8(7.9) | 164(54.6) 61(59.8) | 89(29.7) 33(32.3) |
Test group and matched group compare: X
2=1.76 P＞0.05
Two groups of patients there was no significant difference on the syndrome degree is described, has comparability.
Test method
One. diagnostic criteria
(1) syndrome of dampness-heat blocking collaterals
The redness and swelling of joints burning pain has sense of heaviness, the heating that touch the part, feeling thirst but no desire to drink, red tongue with yellowish and greasy fur, slippery and rapid pulse
(2) Western medicine diagnose standard
According to the therapeutic efficiency of damp and hot numbness (granule, tablet), select sick kind of following doctor trained in Western medicine to carry out clinical observation.
1. rheumatoid arthritis (RA) diagnostic criteria (Americanism damp disease association revision diagnostic criteria in 1987)
(1) morning deadlock at least 1 hour, continued at least 6 weeks.
(2) 3 or the arthroncus more than 3 continued at least 6 weeks.
(3) carpal joint, metacarpophalangeal joints or 6 weeks of nearly articulations digitorum manus swelling or more than.
(4) symmetry arthroncus.
(5) the X line of hands changes.
(6) rheumatoid nodules.
(7) the rheumatoid factor positive.
In above-mentioned 7, have 4 or above person and can be diagnosed as RA.
2. gout (Holmes 1985)
(1) in the leukocyte of synovial bursa hydrops, urate crystal is arranged;
(2) in suction of tophus pin or the biopsy urate crystal is arranged;
(3) do not find special urate crystal, but hyperuricemia is arranged, typical acute arthritis is shown effect and the asymptomatic intermission, and treatment has specially good effect person to colchicine.
3. ankylosing spondylitis diagnostic criteria (the New York standard of revision in 1984)
(1) clinical criteria
1. low back pain continues at least 3 months, can alleviate after the activity, has a rest not have and improves
2. lumbar vertebra is at the limitation of activity of vertical and horizontal plane
3. the thorax mobility be lower than corresponding age, property others
(2) radiology standard
3～4 grades of bilateral sacroiliitis 〉=2 grade or one-sided sacroiliitises
Make a definite diagnosis: meet radiology standard and 1 above clinical criteria.
Two. test case standard
(1) case is included standard in
1. meet above-mentioned tcm syndrome standard and certain Western medicine diagnose person, all can include the object of observation in.
2. the age is between 18～65 years old.
(2) case is got rid of and the rejecting standard
1. do not meet and include standard person in.
2. gestation or women breast-feeding their children, serious primary diseases such as allergic constitution or this medicine allergy sufferers merged is had the inclination, cerebrovascular, liver, kidney, hemopoietic system, psychotic.
3. not medication in accordance with regulations can't be judged the infull person of curative effect or data.
Three. observational technique
(1) medicine
1. test drug: damp and hot arthralgia eliminating granule, damp and hot numbness tablet, specification: granule is the 10g/ bag; Tablet is 0.25g, and being produced by Benxi, Liaoning Province the 3rd pharmaceutical factory provides.
2. contrast medicine: ZHENGQINGFENGTONGNING PIAN, specification are the 20mg/ sheet, produce (authentication code: ZZ-5365 defends in Hunan the accurate word 1992 of medicine No. 023069) by Zhengqing Pharmaceutical Group Corp., Ltd., Hunan Prov., and Benxi the 3rd pharmaceutical factory provides.
(2) test method
1. the object of observation is for being in hospital and the out-patient.
2. grouping: adopt contrast method at random, case is pressed groups of grains: the tablet group: matched group distributes, and ratio is 3: 3: 1.
3. medication: groups of grains, each 1 bag, 3 times on the one; The tablet group, each 6,3 times on the one; Matched group, 2 of first clothes, 3 times on the one, having no adverse reaction after the week adds to each 3, three times on the one.
4. course of treatment: rheumatoid arthritis and ankylosing spondylitis, be 2 months the course of treatment; Gout course of treatment is 1 month.
Four. observation index
(1) safety observation
1. general health check-up project
2. blood, urine, just routine examination
3. electrocardiogram, liver, kidney function test
(2) health giving quality observation
1. symptom grade scale:
1. arthralgia:
0 minute: do not have
1 minute: mild pain, can stand, do not influence sleep.
2 minutes: moderate pain, inertia be pain also.
3 minutes: pain was difficult to stand, and influences function.
2. arthroncus:
0 minute: do not have
1 minute: mild swelling, near bone mark was clear.
2 minutes: swelling was equal with near bone mark.
3 minutes: obviously swelling, bone mark was unclear.
3. articular pain:
0 minute: do not have.
1 minute: weight at the edge, joint or when touching ligament, patient claimed that pain is arranged.
2 minutes: weight patient claimed that pain is arranged, and frowns discomfort, and activity is slightly limited.
3 minutes: the severe tenderness, pressing slightly promptly has pain and shrinks back, and passive activity is seriously limited.
4. morning deadlock:
0 minute: do not have.
1 minute: morning stiff time＜30 minute.
2 minutes: morning stiff time 〉=30 minute,＜60 minutes.
3 minutes: morning stiff time 〉=60 minute.
5. function of joint:
0 minute: function was normal.
1 minute: slightly limited, can be engaged in normal activity.
2 minutes: obviously limited, life can be taken care of oneself, but can not be engaged in general activity.
3 minutes: the movable function forfeiture, can't take care of oneself.
6. the joint heating of touching:
0 minute: do not have
1 minute: have
7. limbs are heavy:
0 minute: do not have
1 minute: have
The mild symptoms major punishment is fixed:
Slightly: integration＜5 minute
Moderate: integration 6～10 minutes
Severe: integration＞10 minute
(2) both hands grip: all write down the numerical value (mmHg) that is reached before and after the treatment.
(3) picture of the tongue pulse condition observation.
(4) laboratory indexes observation: ESR, CRP, RF, blood uric acid.
(5) untoward reaction observation:, itemized record with the relevant untoward reaction of curative possibility.
The symptom efficacy determination:
Control: reduce to 0 fen person through the treatment symptom integral.
Produce effects: reduce by 2 fens persons through the treatment symptom integral.
Effectively: reduce by 1 fen person through the treatment symptom integral.
Five. traditional Chinese medical science disease curative effect determinate standard (according to new Chinese medicine clinical guidance principle standard)
Clinic control: treat the back symptom and disappear substantially, symptom was promptly divided 0～1 fen.
Produce effects: treat the back symptom and be clearly better, symptom is promptly divided decline 〉=2/3
Effectively: treat the back doing well,improving, symptom is promptly divided decline 〉=1/3.
Invalid: as not reach effective standard.
Six. the curative effect of treatment rheumatism sexually transmitted disease (STD) in the curative effect of disease standard (with reference to new drug (Western medicine) clinical guidance principle)
Evaluation criteria.
Clinical remission: symptom, sign disappear, and the laboratory leading indicator is recovered or be approaching normal.
Produce effects: symptom, sign disappear substantially, and the laboratory leading indicator is obviously improved, decline degree 〉=50%.
Effectively: symptom, sign alleviate, and the laboratory leading indicator also has improvement.
Invalid: symptom, sign and laboratory leading indicator do not have improvement.
Annotate: laboratory indexes computational methods erythrocyte sedimentation rate, c reactive protein, numeral-normal value before the numeral-treatment back numeral/treatment before the treatment; 〉=two dilution factors of rheumatoid factor decline
Result of the test
One, total effects analysis: two groups of clinical total effectses of patient relatively see Table 6
Table 6 liang group patient clinical efficacy relatively
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | The above rate of produce effects | Total effective rate | ||||||
| N | (％) | N | (％) | N | (％) | N | (％) | N | (％) | N | (％) | ||
| The test group matched group | 300 102 | 84 14 | (28) (13.7) | 116 36 | (38.7) (35.3) | 72 32 | (24) (33.3) | 28 20 | (9.3) (19.6) | 200 50 | (66.7) (49) | 272 82 | (9.7) (80.4) |
Annotate: * total effective rate=clinic control rate+obvious effective rate+effective percentage
Test group and matched group compare: Ridit analyzes u=3.39 P＜0.001
Two, symptom curative effect
1, two groups of patient's arthralgia treatment front and back curative effects relatively see Table 7.
Curative effect relatively before and after the table 7 liang group patient arthralgia treatment
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | ||||
| N | (％) | N | (％) | N | (％) | N | (％) | ||
| The test group matched group | 300 102 | 98 24 | (32.7) (23.5) | 101 31 | (33.7) (30.4) | 60 37 | (20.4) (36.3) | 30 10 | (10.6) (9.8) |
Test group and matched group compare: U=2.065 P＜0.01
Illustrate: test group is treated symptom efficacious prescriptions face in arthralgia and is better than matched group.
2, two groups of patient's arthroncus treatment front and back curative effects relatively see Table 8.
Curative effect relatively before and after the table 8 liang group patient arthroncus treatment
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | ||||
| N | (％) | N | (％) | N | (％) | N | (％) | ||
| The test group matched group | 287 94 | 91 27 | (39.2) (28.7) | 103 22 | (35.8) (23.4) | 60 25 | (20.9) (26.6) | 33 20 | (11.5) (21.3) |
Test group and matched group compare: U=2.036 P＜0.05
Illustrate that test group is being better than matched group aspect the arthroncus curative effect.
3, two groups of patient's articular pain treatment front and back curative effects relatively see Table 9.
Curative effect relatively before and after the table 9 liang group patient articular pain treatment
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | ||||
| N | (％) | N | (％) | N | (％) | N | (％) | ||
| The test group matched group | 296 85 | 75 13 | (25.3) (15.3) | 104 29 | (35.1) (34.1) | 61 19 | (20.6) (22.3) | 56 24 | (18.9) (28.2) |
Test group and matched group compare: U=2.241 P＜0.05
Illustrate: test group is being better than matched group aspect the articular pain curative effect.
4, two groups of patient's joint function disturbance treatment front and back curative effects relatively see Table 10.
Curative effect relatively before and after the table 10 liang group patient joint function disturbance treatment
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | ||||
| N | (％) | N | (％) | N | (％) | N | (％) | ||
| The test group matched group | 294 93 | 65 6 | (22.1) (6.5) | 72 24 | (24.5) (25.8) | 82 25 | (27.9) (26.9) | 75 38 | (25.5) (40.8) |
Test group and matched group compare, U=3.349 P＜0.001
Test group is being better than matched group aspect the joint function disturbance curative effect.
5, two groups of fever therapy front and back curative effect comparisons that touch in the patient joint see Table 11.
Curative effect relatively before and after the table 11 liang fever therapy that touch in group patient joint
| Group | The example number | N before the treatment | Treatment back N | Disappearance rate | |
| N | (％) | ||||
| The test group matched group | 236 98 | 210 82 | 26 24 | 184 58 | (77.9) (70.7) |
Test group and matched group compare: U=1.722 P＞0.05
Before and after the fever therapy that test group is touched in the joint aspect the curative effect with matched group there was no significant difference relatively.
Three, the curative effect of the two groups of different sick kind treatment of patient front and back relatively.
1. curative effect relatively sees Table 12 before and after the two category rheumatic arthritis patient treatments.
Curative effect relatively before and after the table 12 liang category rheumatic arthritis patient treatment
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | Total effective rate (%) | ||||
| N | (％) | N | (％) | N | (％) | N | (％) | |||
| The test group matched group | 174 69 | 29 10 | (16.7) (14.5) | 47 17 | (27) (24.6) | 79 32 | (45.4) (46.4) | 19 10 | (10.9) (14.5) | 89.1 85.5 |
Test group and matched group compare: Ridit analyzes: u=0.761 P＞0.05
2. two groups of patients with ankylosing spondylitis treatment front and back curative effects relatively see Table 13
Curative effect relatively before and after the table 13 liang group patients with ankylosing spondylitis treatment
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | Total effective rate (%) | ||||
| N | (％) | N | (％) | N | (％) | N | (％) | |||
| The test group matched group | 60 14 | 11 0 | (18.3) | 24 4 | (40) (28.6) | 18 6 | (30) (42.9) | 7 2 | (11.7) (28.5) | 88.3 71.5 |
Test group and matched group compare, and Ridit analyzes: U=2.25 P＜0.05
3. two groups of patient with gout treatment front and back curative effects relatively see Table 14
Curative effect relatively before and after the table 14 liang group patient with gout treatment
| Group | The example number | Clinic control | Produce effects | Effectively | Invalid | Total effective rate (%) | ||||
| N | (％) | N | (％) | N | (％) | N | (％) | |||
| The test group matched group | 54 21 | 8 1 | (14.8) (4.8) | 14 3 | (25.9) (14.3) | 23 9 | (42.5) (42.9) | 9 8 | (16.6) (38) | 83.4 62 |
Test group and matched group compare, and Ridit analyzes: U=2.132 P＜0.05
Four, the two groups of main laboratory indexes treatment of patient front and back curative effects relatively.
1. curative effect relatively sees Table 15 before and after the erythrocyte sedimentation rate treatment
Curative effect compares X ± S before and after the treatment of table 15 erythrocyte sedimentation rate
| The sick kind | Group | The example number | Before the treatment | After the treatment | P |
| RA AS | Test group matched group test group matched group | 174 102 43 14 | 50.24±17.13 41.88±21.52 47.47±13.93 43.4±28.1 | 22.37±11.37 25.2±13.9 26.55±9.87 28.8±16.04 | ＜0.01 ＜0.05 ＜0.05 ＜0.05 |
Illustrate before and after the test group self significant difference is relatively arranged.Significant difference is relatively arranged before and after the matched group self.
2.C curative effect relatively sees Table 16 before and after the reactive protein treatment.
Curative effect relatively before and after the treatment of table 16C reactive protein
| The sick kind | Group | The example number | Before the treatment | After the treatment | Negative conversion rate (%) | P | ||
| Negative | Positive | Negative | Positive | |||||
| RA | The test group matched group | 163 59 | 61 43 | 102 16 | 133 52 | 29 7 | 71.57 56.2 | ＜0.01 ＜0.05 |
| AS | The test group matched group | 38 14 | 21 6 | 17 8 | 36 9 | 5 5 | 66 37.5 | ＜0.05 ＞0.01 |
Illustrate before and after the test group self significant difference is relatively arranged; Compare RA before and after the matched group self the AS there was no significant difference is arranged.
3. curative effect relatively sees Table 17 before and after the treatment of rheumatoid arthritis patients rheumatoid factor.
Curative effect relatively before and after the treatment of table 17 rheumatoid factor
| Group | The example number | Before the treatment | After the treatment | Negative conversion rate (%) | P | ||
| Negative | Positive | Negative | Positive | ||||
| The test group matched group | 163 60 | 27 18 | 136 42 | 40 33 | 103 27 | 24.3 35.7 | ＜0.05 ＜0.01 |
Illustrate before and after the test group self significant difference is relatively arranged; Significant difference is relatively arranged before and after the matched group self.
4. curative effect relatively sees Table 18 before and after the treatment of patient with gout blood uric acid.
Curative effect compares X ± S before and after the treatment of table 18 patient with gout blood uric acid
| Group | The example number | Before the treatment | After the treatment | P |
| The test group matched group | 54 21 | 670.02±119.7 611.6±109.1 | 381.2±124.6 420.4±115.6 | ＜0.01 ＜0.05 |
Illustrate before and after the test group self significant difference is relatively arranged; Significant difference is relatively arranged before and after the matched group self.
Safety detects
In clinical trial, whole experimenters have been carried out the safety detection, the results are shown in Table 20.
Table 20 experimental group patient safety detects
| Project | The example number | Before the treatment | After the treatment | ||
| Normally | Unusually | Normally | Unusually | ||
| Routine blood test routine urinalysis GPT BUN Cr electrocardiogram | 279 279 279 279 279 279 | 267 270 276 278 278 272 | 12 9 2 1 1 7 | 278 279 277 278 278 278 | 1 0 2 1 1 4 |
Illustrate: the unusual patient's kind of 12 routine routine blood tests, 7 examples raise for leukocyte, and most companion's trips are infected, and behind symptomatic treatment, all recover normal; 5 examples reduce for hematochrome, and 4 examples recover normal after treating.During 9 routine routine urinalysis are unusual, be urinary system infection, after treating, recover normal.1 routine blood urea nitrogen and serum creatinine are reduced to patient with gout with slight renal damage.
Untoward reaction
Do not have
Discuss
The resistance of damp and hot numbness is one of common pattern of syndrome in the traditional Chinese medical science rheumatism, and forming reason has the medicine of sweet savoury of surfeit cream and temperature compensation to cause plain body preponderance of YANG QI, in intrinsic heat is arranged, so the damp that is affected by the cold is easily from transconversion into heat; Or with the passing of time disease do not heal, the with the passing of time heat-transformation of heresy that wind and cold is damp and hot, damp and hot numbness resistance joint passages through which vital energy circulates and send out disease all.Ask numbness opinion institute cloud as element: " how cloudy yang-energy gas is few, and pathogenic QI in the body wins, and sun meets with cloudy, so be numbness heat ".Outstanding behaviours is an arthralgia, the heating of laying one's hand on, or the whole body heating is arranged, and red tongue with yellow fur or greasy, rolling pulse or number are more common in rheumatismal active stage performance such as rheumatoid arthritis, ankylosing spondylitis, gout, the basic principle of the wet treatment of clearing away heat-damp and promoting diuresis collateral dredging.According to the Therapeutic Principle of tcm treatment according to syndrome differentiation, on differential diagnosis of diseases and the dialectical basis that combines, use Chinese medicine preparation, can give full play to the advantage of Chinese traditional treatment.Damp and hot numbness sheet is made up of ten several kinds of Chinese medicinal materials such as Rhizoma Atractylodis, Cortex Phellodendri, raw pearl barley, Caulis Lonicerae, Radixs Stephaniae Tetrandrae, cures mainly the damp and hot numbness resistance card in the traditional Chinese medical science rheumatism.This clinical research is according to the principle of traditional Chinese medical science treating different diseases with the same therapeutic principle, adopt the damp and hot numbness sheet of test group respectively, the damp and hot numbness resistance of the traditional Chinese medical science card of matched group ZHENGQINGFENGTONGNING slow releasing tablet treatment rheumatoid arthritis, ankylosing spondylitis, gout, the clinical research result is as follows: 1, two groups of total effectses are compared: test group 300 examples, above 200 examples of produce effects, obvious effective rate is 66.7%; Total effective rate is 90.7%.Matched group 102 examples, obvious effective rate are 49%; Total effective rate is 82%; Two groups of medicine total effectses are compared (P＜0.001) significant differences.2, each symptom curative effect relatively: test group is being compared significant difference with matched group aspect treatment arthralgia, arthroncus, articular pain, the joint function disturbance.3. curative effect of disease relatively: treatment RA total effective rate is 89.1%, compares there was no significant difference with the contrast resistance; Treatment AS total effective rate is 88.3%, and treatment Gout total effective rate is 83.4%, with matched group significant difference is arranged relatively.4. to the influence of main laboratory indexes: test group treatment back ESR, CRP, RF, blood uric acid all have decline, and significant difference is relatively arranged before and after the treatment.5. security inspection: damp and hot numbness sheet does not have obvious adverse reaction, and the heart, liver, kidney, hemogram etc. are all had no adverse effects.
Raising along with people's living standard, the improvement of living environment, the menu routine of high heat etc., modern's physical factors has had great changes than ancients, damp and hot numbness resistance disease day by day in rheumatism more sees, this result of study shows, damp and hot numbness sheet has clearing heat for detumescence really, the effect of removing obstruction in the collateral to relieve pain, not only damp and hot numbness resistance disease there is better curative effect, rheumatoid arthritis, ankylosing spondylitis, gout are also had certain therapeutical effect, are a kind of safe and effective medicine that rheumatism belongs to damp and hot numbness type for the treatment of.
Test unit:
Guang-amen Hospital, China Traditional Chinese Medicine Instl
Shanghai brilliance hospital
Shanghai City institute of traditional Chinese medicine
Henan rheumatism hospital
Luoyang bonesetting hospital
The Beijing Jishuitan Hospital
Hospital Attached to Liaoning Inst. of Traditional Chinese Medicine
Gansu Provincial Hospital of Traditional Chinese Medicine
Tangshan City institute of traditional Chinese medicine
The Provincial Medicine Research Institute, Gansu
466 hospitals of Beijing air force
Benxi Hospital of Traditional Chinese Medicine
The specific embodiment
Embodiment 1
Rhizoma Atractylodis 65.85 Caulis Loniceraes 131.70 Pheretimas 65.85 Fructus Forsythiaes 98.70
Cortex Phellodendri 65.85 Semen Coiciss 131.70 Radix Saposhnikoviaes 65.85 Radix Clematidis 78.90
Radix Stephaniae Tetrandrae 98.70 Radix Cyathulaes 98.70 Rhizoma Dioscoreae Hypoglaucae 98.70 Ramulus Moris 131.70.
Make Chinese medicine preparation according to a conventional method.
Embodiment 2
Rhizoma Atractylodis 60 Caulis Loniceraes 150 Pheretimas 80 Fructus Forsythiaes 100
Cortex Phellodendri 70 Semen Coiciss 110 Radix Saposhnikoviaes 50 Radix Clematidis 80
Radix Stephaniae Tetrandrae 115 Radix Cyathulaes 90 Rhizoma Dioscoreae Hypoglaucae 80 Ramulus Moris 150.
Preparation method is as follows: above 12 flavor medical materials, Fructus Forsythiae, Semen Coicis, Radix Stephaniae Tetrandrae are ground into fine powder, nine flavors such as all the other Pheretimas, decoct with water secondary, add 8 times of amounts of water for the first time, add 6 times of amounts of water for the second time, the each decoction 1.5 hours, collecting decoction filters, and the relative density that filtrate is concentrated into 50 ℃ of surveys is the clear paste of 1.18-1.25; Above-mentioned fine powder and clear paste are granulated, incapsulate, promptly.
Embodiment 3
Rhizoma Atractylodis 50 Caulis Loniceraes 100 Pheretimas 50 Fructus Forsythiaes 80
Cortex Phellodendri 50 Semen Coiciss 100 Radix Saposhnikoviaes 50 Radix Clematidis 55
Radix Stephaniae Tetrandrae 80 Radix Cyathulaes 80 Rhizoma Dioscoreae Hypoglaucae 80 Ramulus Moris 100.
More than 12 flavor medical materials, Fructus Forsythiae, Semen Coicis, Radix Stephaniae Tetrandrae are ground into fine powder, all the other Pheretimas etc. nine flavor decocts with water, collecting decoction filters, the relative density that filtrate is concentrated into 50 ℃ of surveys is the clear paste of 1.10-1.30; Above-mentioned fine powder is mixed with clear paste, and drying is pulverized, and incapsulates, promptly.
Embodiment 4
Rhizoma Atractylodis 60 Caulis Loniceraes 135 Pheretimas 70 Fructus Forsythiaes 110
Cortex Phellodendri 70 Semen Coiciss 135 Radix Saposhnikoviaes 60 Radix Clematidis 90
Radix Stephaniae Tetrandrae 105 Radix Cyathulaes 110 Rhizoma Dioscoreae Hypoglaucae 110 Ramulus Moris 125.
Preparation method is as follows:
1) Rhizoma Atractylodis, Fructus Forsythiae, Radix Saposhnikoviae three flavors extract volatile oil, and the residue medicinal residues discard, and volatile oil and medicinal liquid are standby;
2) press volatile oil: betacyclodextrin=1: 8, colloid milling enclose 3 hours, drying gets volatile oil clathrate compound, and is standby;
3) nine flavors such as all the other Pheretimas, Cortex Phellodendri decoct twice, with 1) the medicinal liquid merging, filter, filtrate is condensed into fluid extract, adds ethanol to leave standstill 12 hours, gets supernatant, and the relative density that recovery ethanol is concentrated into 50 ℃ of surveys is the clear paste of 1.10-1.30;
4) be end powder with the adjuvant, get its clear paste, add volatile oil clathrate compound, the preparation micropill, coating, promptly.
Embodiment 5
Rhizoma Atractylodis 70 Caulis Loniceraes 135 Pheretimas 70 Fructus Forsythiaes 105
Cortex Phellodendri 70 Semen Coiciss 135 Radix Saposhnikoviaes 70 Radix Clematidis 85
Radix Stephaniae Tetrandrae 105 Radix Cyathulaes 105 Rhizoma Dioscoreae Hypoglaucae 105 Ramulus Moris 135.
Preparation method is as follows:
Fructus Forsythiae, Semen Coicis, Radix Stephaniae Tetrandrae are ground into fine powder, and be standby.Nine flavors such as all the other Pheretimas, Cortex Phellodendri decoct twice, and each 2 hours, merge medicinal liquid, filter, centrifugal, the relative density that filtrate is concentrated into 50 ℃ of surveys is the clear paste of 1.10-1.30; With adjuvant and crude drug powder is end powder, gets its clear paste, the preparation micropill, and coating, promptly.
Embodiment 6
Rhizoma Atractylodis 75 Caulis Loniceraes 125 Pheretimas 60 Fructus Forsythiaes 95
Cortex Phellodendri 70 Semen Coiciss 115 Radix Saposhnikoviaes 70 Radix Clematidis 85
Radix Stephaniae Tetrandrae 100 Radix Cyathulaes 100 Rhizoma Dioscoreae Hypoglaucae 95 Ramulus Moris 130.
Preparation method is as follows:
1) Rhizoma Atractylodis, Fructus Forsythiae, Radix Saposhnikoviae three flavors extract volatile oil, and the residue medicinal residues discard, and volatile oil and medicinal liquid are standby;
2) press volatile oil: betacyclodextrin=1: 8, colloid milling enclose 3 hours, drying gets volatile oil clathrate compound, and is standby;
3) nine flavors such as all the other Pheretimas, Cortex Phellodendri decoct twice, with 1) the medicinal liquid merging, filter, filtrate is condensed into fluid extract, adds ethanol to leave standstill 12 hours, gets supernatant, and the relative density that recovery ethanol is concentrated into 50 ℃ of surveys is the clear paste of 1.10-1.30;
4) be end powder with the adjuvant, get its clear paste, add volatile oil clathrate compound, the preparation micropill, promptly.
Embodiment 7
Rhizoma Atractylodis 80 Caulis Loniceraes 100 Pheretimas 80 Fructus Forsythiaes 80
Cortex Phellodendri 80 Semen Coiciss 120 Radix Saposhnikoviaes 70 Radix Clematidis 95
Radix Stephaniae Tetrandrae 90 Radix Cyathulaes 110 Rhizoma Dioscoreae Hypoglaucae 100 Ramulus Moris 100.
Preparation method is as follows:
Fructus Forsythiae, Semen Coicis, Radix Stephaniae Tetrandrae are ground into fine powder, and be standby.Nine flavors such as all the other Pheretimas, Cortex Phellodendri decoct twice, and each 2 hours, merge medicinal liquid, filter, centrifugal, the relative density that filtrate is concentrated into 50 ℃ of surveys is the clear paste of 1.10-1.30; With adjuvant and crude drug powder is end powder, gets its clear paste, the preparation micropill, promptly.
Embodiment 8
Rhizoma Atractylodis 65.85 Caulis Loniceraes 131.70 Pheretimas 65.85 Fructus Forsythiaes 98.70
Cortex Phellodendri 65.85 Semen Coiciss 131.70 Radix Saposhnikoviaes 65.85 Radix Clematidis 78.90
Radix Stephaniae Tetrandrae 98.70 Radix Cyathulaes 98.70 Rhizoma Dioscoreae Hypoglaucae 98.70 Ramulus Moris 131.70
Preparation method is as follows:
1) Rhizoma Atractylodis, Fructus Forsythiae, Radix Saposhnikoviae three flavors extract volatile oil, and the residue medicinal residues discard, and volatile oil and medicinal liquid are standby;
2) press volatile oil: betacyclodextrin=1: 4-10, the colloid milling enclose, drying gets volatile oil clathrate compound, and is standby;
3) nine flavors such as all the other Pheretimas, Cortex Phellodendri decoct with water 2 times, and each 2 hours, the gained medical filtration, merging filtrate is with 1) the medicinal liquid merging, filtrate is concentrated into fluid extract, and is standby;
4) getting above-mentioned clear paste adds ethanol and makes and contain alcohol amount and reach 65%.Above-mentioned medicinal liquid is stirred evenly, left standstill 24 hours.Get supernatant, decompression recycling ethanol, the clear paste that to be concentrated into 80 ℃ of relative densities be 1.20-1.30, standby;
5) with above-mentioned clear paste, volatile oil bag and thing and proper auxiliary materials mixing are granulated, and drying is made dispersible tablet, and packing promptly.
Claims (14)
- One kind the treatment damp and hot numbness Chinese medicine, it is characterized in that it is prepared from by acceptable auxiliary on following weight parts proportion raw material and the pharmaceutics:Rhizoma Atractylodis 50-80 Caulis Lonicerae 100-150 Pheretima 50-80 Fructus Forsythiae 80-115Cortex Phellodendri 50-80 Semen Coicis 100-150 Radix Saposhnikoviae 50-80 Radix Clematidis 55-95Radix Stephaniae Tetrandrae 80-115 Radix Cyathulae 80-115 Rhizoma Dioscoreae Hypoglaucae 80-115 Ramulus Mori 100-150.
- 2. Chinese medicine according to claim 1 is characterized in that the weight portion of raw material is:Rhizoma Atractylodis 60-70 Caulis Lonicerae 125-135 Pheretima 60-70 Fructus Forsythiae 95-105Cortex Phellodendri 60-70 Semen Coicis 125-135 Radix Saposhnikoviae 60-70 Radix Clematidis 75-85Radix Stephaniae Tetrandrae 95-105 Radix Cyathulae 95-105 Rhizoma Dioscoreae Hypoglaucae 95-105 Ramulus Mori 125-135.
- 3. Chinese medicine according to claim 1 is characterized in that the weight portion of raw material is:Rhizoma Atractylodis 50 Caulis Loniceraes 100 Pheretimas 50 Fructus Forsythiaes 80Cortex Phellodendri 50 Semen Coiciss 100 Radix Saposhnikoviaes 50 Radix Clematidis 55Radix Stephaniae Tetrandrae 80 Radix Cyathulaes 80 Rhizoma Dioscoreae Hypoglaucae 80 Ramulus Moris 100.
- 4. Chinese medicine according to claim 1 is characterized in that the weight portion of raw material is:Rhizoma Atractylodis 60 Caulis Loniceraes 135 Pheretimas 70 Fructus Forsythiaes 110Cortex Phellodendri 70 Semen Coiciss 135 Radix Saposhnikoviaes 60 Radix Clematidis 90Radix Stephaniae Tetrandrae 105 Radix Cyathulaes 110 Rhizoma Dioscoreae Hypoglaucae 110 Ramulus Moris 125.
- 5. Chinese medicine according to claim 1 is characterized in that the weight portion of raw material is:Rhizoma Atractylodis 70 Caulis Loniceraes 135 Pheretimas 70 Fructus Forsythiaes 105Cortex Phellodendri 70 Semen Coiciss 135 Radix Saposhnikoviaes 70 Radix Clematidis 85Radix Stephaniae Tetrandrae 105 Radix Cyathulaes 105 Rhizoma Dioscoreae Hypoglaucae 105 Ramulus Moris 135.
- 6. Chinese medicine according to claim 1 is characterized in that the weight portion of raw material is:Rhizoma Atractylodis 80 Caulis Loniceraes 100 Pheretimas 80 Fructus Forsythiaes 80Cortex Phellodendri 80 Semen Coiciss 100 Radix Saposhnikoviaes 80 Radix Clematidis 95Radix Stephaniae Tetrandrae 80 Radix Cyathulaes 80 Rhizoma Dioscoreae Hypoglaucae 80 Ramulus Moris 100.
- 7. Chinese medicine according to claim 1 is characterized in that the weight portion of raw material is:Rhizoma Atractylodis 65.85 Caulis Loniceraes 131.70 Pheretimas 65.85 Fructus Forsythiaes 98.70Cortex Phellodendri 65.85 Semen Coiciss 131.70 Radix Saposhnikoviaes 65.85 Radix Clematidis 78.90Radix Stephaniae Tetrandrae 98.70 Radix Cyathulaes 98.70 Rhizoma Dioscoreae Hypoglaucae Pis 98.70 Ramulus Moris 131.70.
- 8. according to each described Chinese medicine of claim 1-7, it is characterized in that: this Chinese medicine is tablet, granule, capsule, pellet or dispersible tablet.
- 9. preparation method of Chinese medicine according to claim 8, it is characterized in that comprising the following steps: above 12 flavor medical materials, Fructus Forsythiae, Semen Coicis, Radix Stephaniae Tetrandrae are ground into fine powder, nine flavors such as all the other Pheretimas, decoct with water, collecting decoction filters, and the relative density of surveying when filtrate is concentrated into 50 ℃ is the clear paste of 1.10-1.30; Above-mentioned fine powder and clear paste are granulated, incapsulate, promptly.
- 10. preparation method of Chinese medicine according to claim 8, it is characterized in that comprising the following steps: above 12 flavor medical materials, Fructus Forsythiae, Semen Coicis, Radix Stephaniae Tetrandrae are ground into fine powder, nine flavors such as all the other Pheretimas, decoct with water, collecting decoction filters, and the relative density of surveying when filtrate is concentrated into 50 ℃ is the clear paste of 1.10-1.30; Above-mentioned fine powder is mixed with clear paste, and drying is pulverized, and incapsulates, promptly.
- 11. preparation method of Chinese medicine according to claim 8 is characterized in that:1) Rhizoma Atractylodis, Fructus Forsythiae, Radix Saposhnikoviae three flavors extract volatile oil, and medicinal residues discard, and volatile oil and medicinal liquid are standby;2) press volatile oil: betacyclodextrin=1: the 4-10 enclose, get volatile oil clathrate compound, standby;3) nine flavors such as all the other Pheretimas, Cortex Phellodendri decoct with water 2-3 time, and each 1-2 hour, the gained medical filtration, merging filtrate is with 1) the medicinal liquid merging, filtrate is concentrated into fluid extract, and is standby;4) getting above-mentioned fluid extract adds ethanol and makes the alcohol amount of containing reach 50-80%; Above-mentioned medicinal liquid is stirred evenly, leave standstill; Get supernatant, decompression recycling ethanol, the relative density that is concentrated into 50 ℃ of surveys is the clear paste of 1.20-1.30, and is standby;5) with above-mentioned clear paste, volatile oil clathrate compound and proper auxiliary materials are granulated, and incapsulate promptly.
- 12. preparation method of Chinese medicine according to claim 8 is characterized in that comprising the following steps;1) Rhizoma Atractylodis, Fructus Forsythiae, Radix Saposhnikoviae three flavors extract volatile oil, and medicinal residues discard, and volatile oil and medicinal liquid are standby;2) press volatile oil: betacyclodextrin=1: 4-10, enclose gets volatile oil clathrate compound, and is standby;3) nine flavors such as all the other Pheretimas, Cortex Phellodendri decoct twice, with 1) the medicinal liquid merging, filter, filtrate is condensed into fluid extract, adds ethanol to leave standstill, and gets supernatant, and reclaiming the relative density of surveying when ethanol is concentrated into 50 ℃ is the clear paste of 1.10-1.30.Get its clear paste, add volatile oil clathrate compound and adjuvant, the preparation micropill; Perhaps, with the micropill coating; Promptly.
- 13. preparation method of Chinese medicine according to claim 8 is characterized in that comprising the following steps: that Fructus Forsythiae, Semen Coicis, Radix Stephaniae Tetrandrae are ground into fine powder, and is standby; Nine flavors such as all the other Pheretimas, Cortex Phellodendri decoct twice, merge medicinal liquid, filter, and centrifugal, the relative density that filtrate is concentrated into 50 ℃ of surveys is the clear paste of 1.10-1.30; Get its clear paste, add adjuvant and crude drug powder, the preparation micropill; Perhaps, with the micropill coating; Promptly.
- 14. preparation method of Chinese medicine according to claim 8 is characterized in that:1) Rhizoma Atractylodis, Fructus Forsythiae, Radix Saposhnikoviae three flavors extract volatile oil, and medicinal residues discard, and volatile oil and medicinal liquid are standby;2) press volatile oil: betacyclodextrin=1: the 4-10 enclose, get volatile oil clathrate compound, standby;3) nine flavors such as all the other Pheretimas, Cortex Phellodendri decoct with water 2-3 time, and each 1-2 hour, the gained medical filtration, merging filtrate is with 1) the medicinal liquid merging, filtrate is concentrated into fluid extract, and is standby;4) getting above-mentioned fluid extract adds ethanol and makes the alcohol amount of containing reach 50-80%; Above-mentioned medicinal liquid is stirred evenly, leave standstill; Get supernatant, decompression recycling ethanol, the relative density that is concentrated into 50 ℃ of surveys is the clear paste of 1.20-1.30, and is standby;5) with above-mentioned clear paste, volatile oil clathrate compound and proper auxiliary materials are granulated, and drying is made dispersible tablet.
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